Olympus recalls Toomey Evacuator 50cc with Adaptor (Model 188A) due to potential failure to sterilize medical devices. Affected units may not render devices adequately sterile, risking infection.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Olympus is recalling its Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization settings in the user manual might not properly sterilize medical devices. This could lead to infections if the device is used without proper sterilization.
The device's sterilization parameters in the user manual may not consistently ensure medical devices are sterile. If the device is used without proper sterilization, it could lead to infections in patients.
Healthcare professionals and medical facilities using the Olympus Toomey Evacuator 50cc with Adaptor (Model 188A) are most at risk. The recall affects all units sold with this model number.
Check for the model number 188A on the device. All units with this model number are affected, regardless of lot number or serial number.
Review the user manual for sterilization parameters to ensure they are followed correctly.
The device may not consistently sterilize medical devices, so it should not be used without proper sterilization settings.
Check the model number on the device; if it is 188A, review sterilization settings in the user manual to ensure proper use.
The recall does not provide a fix; users must follow sterilization settings in the user manual to avoid infection risks.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2719-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2719-2026 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
